Latest Drugwonks' Blog
Want the facts and nothing but the facts on Medicare Advantage?
Of course you do, you're a drugwonk!
Have a look at this document:
Download file
CMPI is glad to have assisted in putting this fact sheet together.
Of course you do, you're a drugwonk!
Have a look at this document:
Download file
CMPI is glad to have assisted in putting this fact sheet together.
Here's a link to the complete BioCentury feature, "Deconstructing FDAMA."
Download file
Many thanks to Bard Steve and BioCentury for the permission to share.
Download file
Many thanks to Bard Steve and BioCentury for the permission to share.
Steve Usdin certainly has a way with words. Consider these pearls from the recent edition of BioCentury:
"Part of the lesson from FDAMA is that the road to regulatory perdition is paved with the best legislative intentions.
The fact is the Congress did not accompany its 1997 mandate for new treatments with any risks for FDA's failure to perform, and hasn't followed through with the resources to bring regulatory science into the 21st century.
Lawmakers also lost interest in the outcome, and now have turned their attention to raising political capital by easy grandstanding about safety.
The truth is that neither Vioxx nor anti-depressants, nor Ketek rise to the level of thalidomide. If it were so, then there would be a groundswell of calls to roll back FDAMA's mandate to being new treatments to patients who need them.
But even if there is no return to the pre-1997 era de jure, a de facto rollback is a real possibility unless Congress, regulators, patients and industry again are willing to do the hard work required to build the sophisticated systems to improve the risk-benefit calculus. This revived collaboration is necessary to make palatable the regulatory risk that everyone must accept if the new science is to make its way to the bedside."
We hereby dub Sir Steve the "Bard of BioCentury."
"Part of the lesson from FDAMA is that the road to regulatory perdition is paved with the best legislative intentions.
The fact is the Congress did not accompany its 1997 mandate for new treatments with any risks for FDA's failure to perform, and hasn't followed through with the resources to bring regulatory science into the 21st century.
Lawmakers also lost interest in the outcome, and now have turned their attention to raising political capital by easy grandstanding about safety.
The truth is that neither Vioxx nor anti-depressants, nor Ketek rise to the level of thalidomide. If it were so, then there would be a groundswell of calls to roll back FDAMA's mandate to being new treatments to patients who need them.
But even if there is no return to the pre-1997 era de jure, a de facto rollback is a real possibility unless Congress, regulators, patients and industry again are willing to do the hard work required to build the sophisticated systems to improve the risk-benefit calculus. This revived collaboration is necessary to make palatable the regulatory risk that everyone must accept if the new science is to make its way to the bedside."
We hereby dub Sir Steve the "Bard of BioCentury."
Henry Waxman supports a bill that would limit the FDA's control over the distribution of pot for medical purposes less than it would limit a doctor's use of new medicines that undergo FDA approval.
Here is the relevant portion of the States Right to Medical Marijuana Act
FEDERAL FOOD, DRUG, AND COSMETIC ACT.
(a) In General- No provision of the Federal Food, Drug, and Cosmetic Act shall prohibit or otherwise restrict--
(1) the prescription or recommendation of marijuana by a physician for medical use,
(2) an individual from obtaining and using marijuana from a prescription or recommendation of marijuana by a physician for medical use by such individual, or
(3) a pharmacy from obtaining and holding marijuana for the prescription or recommendation of marijuana by a physician for medical use,
in a State in which marijuana may be prescribed or recommended by a physician for medical use under applicable State law.
(b) Production- No provision of the Federal Food, Drug, and Cosmetic Act shall prohibit or otherwise restrict an entity established by a State, in which marijuana may be prescribed or recommended by a physician for medical use, for the purpose of producing marijuana for prescription or recommendation by a physician for medical use from producing and distributing marijuana for such purpose.
Compare that to the civil penalties handed out to anyone violating any aspect of any risk management plan doled out by the FDA under Waxman's watchful eye,
Waxman said of those who opposed a bill to give states the right to regulate the use of marijuana for medical purposes: They "think we should just say no to sick and dying patients because it looks like we're getting tough on drugs."
Is that like saying no to sick and dying patients because it looks like we are getting tough on drug safety?
PS. See the following article
High School Students Getting Medical Marijuana Cards In California
Some California teens are giving a new meaning to "high" school.
Students are finding easy access to medical marijuana cards and presenting those cards to school authorities as a legitimate excuse for getting high.
Advertisement
But, where are the cards coming from?
A letter was sent home to parents of students in the Grossmont Union High School District.
"It's not a get out of jail free card at all." Catherine Martin says even though medical marijuana is legal in California, the law doesn't apply to schools which are subject to federal law. The district also says the students most recently suspended for being high with cards in hand - didn't have major illnesses.
"Students are getting them for things like sleeplessness and stress - it just draws into question how easy is it for people to get their hands on these cards."
Well, at least they are not promoting off-label drug use....
http://www.ksdk.com/news/news_article.aspx?storyid=114394
Here is the relevant portion of the States Right to Medical Marijuana Act
FEDERAL FOOD, DRUG, AND COSMETIC ACT.
(a) In General- No provision of the Federal Food, Drug, and Cosmetic Act shall prohibit or otherwise restrict--
(1) the prescription or recommendation of marijuana by a physician for medical use,
(2) an individual from obtaining and using marijuana from a prescription or recommendation of marijuana by a physician for medical use by such individual, or
(3) a pharmacy from obtaining and holding marijuana for the prescription or recommendation of marijuana by a physician for medical use,
in a State in which marijuana may be prescribed or recommended by a physician for medical use under applicable State law.
(b) Production- No provision of the Federal Food, Drug, and Cosmetic Act shall prohibit or otherwise restrict an entity established by a State, in which marijuana may be prescribed or recommended by a physician for medical use, for the purpose of producing marijuana for prescription or recommendation by a physician for medical use from producing and distributing marijuana for such purpose.
Compare that to the civil penalties handed out to anyone violating any aspect of any risk management plan doled out by the FDA under Waxman's watchful eye,
Waxman said of those who opposed a bill to give states the right to regulate the use of marijuana for medical purposes: They "think we should just say no to sick and dying patients because it looks like we're getting tough on drugs."
Is that like saying no to sick and dying patients because it looks like we are getting tough on drug safety?
PS. See the following article
High School Students Getting Medical Marijuana Cards In California
Some California teens are giving a new meaning to "high" school.
Students are finding easy access to medical marijuana cards and presenting those cards to school authorities as a legitimate excuse for getting high.
Advertisement
But, where are the cards coming from?
A letter was sent home to parents of students in the Grossmont Union High School District.
"It's not a get out of jail free card at all." Catherine Martin says even though medical marijuana is legal in California, the law doesn't apply to schools which are subject to federal law. The district also says the students most recently suspended for being high with cards in hand - didn't have major illnesses.
"Students are getting them for things like sleeplessness and stress - it just draws into question how easy is it for people to get their hands on these cards."
Well, at least they are not promoting off-label drug use....
http://www.ksdk.com/news/news_article.aspx?storyid=114394
Mark McClellan in this week's BioCentury:
"When you have an adverse event reporting system that only captures about 10% of events, that does it with variable time lags, and with inconsistentely collected information, and isn't linked to an adequate infrastructure at the FDA to analyze the information, no wonder there is real public concern."
"When you have an adverse event reporting system that only captures about 10% of events, that does it with variable time lags, and with inconsistentely collected information, and isn't linked to an adequate infrastructure at the FDA to analyze the information, no wonder there is real public concern."
After reading Daniel Costello's article in the LA Times "Setting a Price for Putting Off Death," I fired off an angry letter to him basically accusing him of favoring rationing and of being heartless.
He called me back and let me have it. I deserved it and he deserved better.
The article is excellent. And it raises an important question about whether our health care system is designed to invest in life or not. More important, I might be upset that some people might think about putting a price on life but I was way out of line.
http://www.latimes.com/business/la-fi-life18mar18,1,2591501.story?page=2&track=rss
He called me back and let me have it. I deserved it and he deserved better.
The article is excellent. And it raises an important question about whether our health care system is designed to invest in life or not. More important, I might be upset that some people might think about putting a price on life but I was way out of line.
http://www.latimes.com/business/la-fi-life18mar18,1,2591501.story?page=2&track=rss
Frank Burroughs that is, of the Abigail Alliance.
Frank called me yesterday to discuss an article in the March issue of Medical Marketing & Media entitled, "Are NDA Laws Constitutional." He felt that my comments were used to undercut the policy position of the Abigail Alliance.
So I went back to the article and, although I stand by every single one of my quotes, Frank is right in pointing out that the context in which they were used could lead you to think I fundamentally disagree with his position on the issue.
Not so. Not at all. And I feel it's important that I make this point without any ambiguity.
Here is a link to the article:
http://www.mmm-online.com/content/index.php?id=77&no_cache=1&tx_magissue_pi1[pointer]=0&tx_magissue_pi1[showUid]=428
That's good for Frank. And it's good sense.
Frank called me yesterday to discuss an article in the March issue of Medical Marketing & Media entitled, "Are NDA Laws Constitutional." He felt that my comments were used to undercut the policy position of the Abigail Alliance.
So I went back to the article and, although I stand by every single one of my quotes, Frank is right in pointing out that the context in which they were used could lead you to think I fundamentally disagree with his position on the issue.
Not so. Not at all. And I feel it's important that I make this point without any ambiguity.
Here is a link to the article:
http://www.mmm-online.com/content/index.php?id=77&no_cache=1&tx_magissue_pi1[pointer]=0&tx_magissue_pi1[showUid]=428
That's good for Frank. And it's good sense.
http://news.yahoo.com/s/ap/20070320/ap_on_he_me/alzheimer_s
Latest estimate of people living with Alzheimer's is up to 5 million. Meanwhile as Steve Usdin's excellent piece in Biocentury demonstrates, the FDA Modernization Act of 1997 has done nothing to accelerate the pace of bringing new drugs to people.
Which is why the FDA pushed for Critical Path
Meanwhile Congress ignores the growing Alzheimer problem. Indeed, it seems determined to make it worse. It fiddles with making the FDA decision making process longer and more expensive and so-called medical experts flush with money from junk science litigation about silicone breast implants (defendscience.org) claim that user fees have made more people less safe. (Without any evidence to back it up, but what else is new?) These same people also want follow on biologics to flow like tap water free from the same safety standards they would impose on old medicines.
On a related subject,even if a new drug for Alzheimer's was approved and it cost $10000 a year to stave off onset by 1-3 years, my guess is that the media would question whether medicines that don't cure such a disease are worth it. Don't believe me? Just look at the piece of garbage Daniel Costello of the LA Times wrote about cancer drugs this past Sunday. He basically asked if 3 months of life is worth $40k?
Let him cut short his own life and family to save some cash before he makes that decision for society.
http://www.latimes.com/business/la-fi-life18mar18,1,2591501.story?track=rss
By LAURAN NEERGAARD, AP Medical Writer Tue Mar 20, 6:51 AM ET
WASHINGTON - More than 5 million Americans are living with
Alzheimer's disease, a 10 percent increase since the last Alzheimer's Association estimate five years ago — and a count that supports the long-forecast dementia epidemic as the population grays.
Age is the biggest risk factor, and the report to be released Tuesday shows the nation is on track for skyrocketing Alzheimer's once the baby boomers start turning 65 in 2011. Already, one in eight people 65 and older have the mind-destroying illness, and nearly one in two people over 85.
Unless scientists discover a way to delay Alzheimer's brain attack, some 7.7 million people are expected to have the disease by 2030, the report says. By 2050, that toll could reach 16 million.
Latest estimate of people living with Alzheimer's is up to 5 million. Meanwhile as Steve Usdin's excellent piece in Biocentury demonstrates, the FDA Modernization Act of 1997 has done nothing to accelerate the pace of bringing new drugs to people.
Which is why the FDA pushed for Critical Path
Meanwhile Congress ignores the growing Alzheimer problem. Indeed, it seems determined to make it worse. It fiddles with making the FDA decision making process longer and more expensive and so-called medical experts flush with money from junk science litigation about silicone breast implants (defendscience.org) claim that user fees have made more people less safe. (Without any evidence to back it up, but what else is new?) These same people also want follow on biologics to flow like tap water free from the same safety standards they would impose on old medicines.
On a related subject,even if a new drug for Alzheimer's was approved and it cost $10000 a year to stave off onset by 1-3 years, my guess is that the media would question whether medicines that don't cure such a disease are worth it. Don't believe me? Just look at the piece of garbage Daniel Costello of the LA Times wrote about cancer drugs this past Sunday. He basically asked if 3 months of life is worth $40k?
Let him cut short his own life and family to save some cash before he makes that decision for society.
http://www.latimes.com/business/la-fi-life18mar18,1,2591501.story?track=rss
By LAURAN NEERGAARD, AP Medical Writer Tue Mar 20, 6:51 AM ET
WASHINGTON - More than 5 million Americans are living with
Alzheimer's disease, a 10 percent increase since the last Alzheimer's Association estimate five years ago — and a count that supports the long-forecast dementia epidemic as the population grays.
Age is the biggest risk factor, and the report to be released Tuesday shows the nation is on track for skyrocketing Alzheimer's once the baby boomers start turning 65 in 2011. Already, one in eight people 65 and older have the mind-destroying illness, and nearly one in two people over 85.
Unless scientists discover a way to delay Alzheimer's brain attack, some 7.7 million people are expected to have the disease by 2030, the report says. By 2050, that toll could reach 16 million.
From the current edition of FDA News ...
Experts Question Effect of FDA's New Office of Integrity and Accountability
by Christopher Hollis
FDA Commissioner Andrew von Eschenbach's establishment of a new Office of Integrity and Accountability to address cultural issues within the agency might be a "nice" idea but is not necessary for accomplishing the FDA's mission, according to Peter Pitts, director of the Center for Medicine in the Public Interest (CMPI).
The initiative is just "placating critics on Capitol Hill" and could divert resources away from the FDA's mission, Pitts noted. It is wrong for politics to drive agency policy, Pitts said.
Von Eschenbach announced the creation of the new office during PhRMA's annual board meeting March 15.
However, CMPI Vice President Robert Goldberg said that the creation of the office was a good move for the FDA. "I think what von Eschenbach is trying to do is bring some order to the frat house."
"What he is doing, I think, with this office is giving people who have a grievance or feel that they've been side-stepped an opportunity to . vent and formally present their case to the commissioner, instead of having it fester as some kind of internal squabble within the ranks." That's a smart idea, he added, "and the right thing to do, rather than taking it to Congress where the data and the claims go unfiltered right to the media."
One of the issues the new office will handle is managing conflicts of interest for advisory committee members. Pitts, who dealt with advisory committee issues while serving during the first term of the Bush administration as the FDA's associate commissioner for external relations, noted that restrictive policies regarding conflicts of interest for committees are not conducive to retaining the best and the brightest scientists.
Instead of the best and the brightest, you get "almost the best and kind of the brightest," Pitts said. Goldberg echoed Pitts' sentiment regarding restrictive conflict of interest policies, specifically those set forth by the Institute of Medicine and in S.484, the "Enhancing Drug Safety and Innovation Act of 2007," introduced by Sens. Edward Kennedy (D-Mass.) and
Mike Enzi (R-Wyo.).
"It's ridiculous. People who have won Nobel prizes in pharmacology or medicinal chemistry would have been excluded [as members], both by the recommendations made by the Institute of Medicine and by the standards set forth in [S.484]," Goldberg said.
Experts Question Effect of FDA's New Office of Integrity and Accountability
by Christopher Hollis
FDA Commissioner Andrew von Eschenbach's establishment of a new Office of Integrity and Accountability to address cultural issues within the agency might be a "nice" idea but is not necessary for accomplishing the FDA's mission, according to Peter Pitts, director of the Center for Medicine in the Public Interest (CMPI).
The initiative is just "placating critics on Capitol Hill" and could divert resources away from the FDA's mission, Pitts noted. It is wrong for politics to drive agency policy, Pitts said.
Von Eschenbach announced the creation of the new office during PhRMA's annual board meeting March 15.
However, CMPI Vice President Robert Goldberg said that the creation of the office was a good move for the FDA. "I think what von Eschenbach is trying to do is bring some order to the frat house."
"What he is doing, I think, with this office is giving people who have a grievance or feel that they've been side-stepped an opportunity to . vent and formally present their case to the commissioner, instead of having it fester as some kind of internal squabble within the ranks." That's a smart idea, he added, "and the right thing to do, rather than taking it to Congress where the data and the claims go unfiltered right to the media."
One of the issues the new office will handle is managing conflicts of interest for advisory committee members. Pitts, who dealt with advisory committee issues while serving during the first term of the Bush administration as the FDA's associate commissioner for external relations, noted that restrictive policies regarding conflicts of interest for committees are not conducive to retaining the best and the brightest scientists.
Instead of the best and the brightest, you get "almost the best and kind of the brightest," Pitts said. Goldberg echoed Pitts' sentiment regarding restrictive conflict of interest policies, specifically those set forth by the Institute of Medicine and in S.484, the "Enhancing Drug Safety and Innovation Act of 2007," introduced by Sens. Edward Kennedy (D-Mass.) and
Mike Enzi (R-Wyo.).
"It's ridiculous. People who have won Nobel prizes in pharmacology or medicinal chemistry would have been excluded [as members], both by the recommendations made by the Institute of Medicine and by the standards set forth in [S.484]," Goldberg said.
May I recommend Unlocking Ideas: Essays from the Amigo Society.
Edited by Francesca Ficai; Introduction by Jacob Arfwedson; Arne Björnberg; Manuel Campolini; Pat Cox; Brian Crowley; Duncan Curley; Johan Hjertqvist; Pavel Hrobon; Johnny Munkhammar, Peter Pitts, Jan Remans, Anders Sandberg.
The Amigo Society conferences, held in Brussels, were set up in 2004 to bring together public policy experts, media representatives and members of civil society to debate these and other issues of importance to an enlarged Europe.
Taking concrete examples from all over Europe and North America, this collection examines the broad motivations behind, influences on, and opportunities for future health and welfare policy reform. It also looks to the future – drawing in new fields of policymaking such as biotechnology, tailormade medicines and other technologies expected to drastically alter Europe’s healthcare landscape.
And driving it all, the final set of essays examines consumer empowerment as the major factor which will push forward reform of Europe’s health and welfare systems.
The book can be found at:
http://www.stockholm-network.org/publications/list.php#75
Unlocking Ideas: Essays from the Amigo Society assembles the highlights of these debates over the past two years and provides exciting new insights for the reformers of the future.
Edited by Francesca Ficai; Introduction by Jacob Arfwedson; Arne Björnberg; Manuel Campolini; Pat Cox; Brian Crowley; Duncan Curley; Johan Hjertqvist; Pavel Hrobon; Johnny Munkhammar, Peter Pitts, Jan Remans, Anders Sandberg.
The Amigo Society conferences, held in Brussels, were set up in 2004 to bring together public policy experts, media representatives and members of civil society to debate these and other issues of importance to an enlarged Europe.
Taking concrete examples from all over Europe and North America, this collection examines the broad motivations behind, influences on, and opportunities for future health and welfare policy reform. It also looks to the future – drawing in new fields of policymaking such as biotechnology, tailormade medicines and other technologies expected to drastically alter Europe’s healthcare landscape.
And driving it all, the final set of essays examines consumer empowerment as the major factor which will push forward reform of Europe’s health and welfare systems.
The book can be found at:
http://www.stockholm-network.org/publications/list.php#75
Unlocking Ideas: Essays from the Amigo Society assembles the highlights of these debates over the past two years and provides exciting new insights for the reformers of the future.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
